STARTER REGENflex Medical Device CE, Class III, based on highly purified hyaluronic acid with a molecular weight between 800 and 1,200 kDalton. Sodium hyaluronate represents a key component of synovial fluid, being responsible for its special viscoelastic properties. The sodium hyaluronate in REGENflex is obtained by fermentation, excluding any chemical modification treatment, to ensure an absolutely pure product free of residues foreign to the physiological context of use. REGENflex STARTER is an injectable product based on a 1.6 percent buffered saline solution of hyaluronic acid sodium salt with remarkable viscoelastic properties.
In traumatic and degenerative joint diseases, there is a decrease in the amount of hyaluronic acid in situ, resulting in reduced viscosity of synovial fluid. This deficiency results in impaired joint function and painful symptoms. Intra-articular administration of hyaluronic acid is able to restore the viscoelastic properties of synovial fluid, resulting in pain relief, a marked anti-inflammatory response, and improved joint mobility. The REGENflex protocol involves a two-stage intervention: the first consists of three interventions on a weekly basis, performed with REGENflex STARTER 1.6%, with the aim of favorably conditioning the joint compartment through impaction, reducing the symptomatology of the affection and maintaining a prolonged stay in situ (by virtue of the increased concentration). Subsequent infiltrations (5 interventions weekly), performed with REGENflex 0.8%, will perform a maintenance and stabilization function. REGENflex exhibits excellent tolerability, however, acting only locally (in the joint compartment where it is injected), excluding any systemic actions.
Mode of use
Infiltrate intra-articularly 2 ml of product once a week for 3 weeks, unless otherwise advised by the physician and according to the patient’s condition. If further courses of treatment are needed, a 6-month interval is recommended. In the judgment of the physician, depending on the patient’s health condition, multiple joints can be treated simultaneously.
Aspirate any joint effusion before injecting REGENflex STARTER. Pull the cap out of the syringe taking special care in order to avoid contact with the opening. Insert an appropriately sized needle (18 to 22 G) by screwing it in tightly to ensure a tight seal and prevent solution spillage. Inject the device only within the synovial space, at room temperature and under strictly aseptic conditions.
The device is sold by prescription only. Intra-articular injection should be performed only by a physician. Do not use after the expiration date on the package. Do not use if the packaging is opened or damaged. The area where the injection is given must be on healthy skin. Do not inject vascularly. Do not inject into the knee joint if there is venous or lymphatic stasis in the limb. Do not inject outside the joint cavity, into synovial tissue or the joint capsule. Do not administer in the presence of severe intra-articular effusion. REGENflex STARTER should not be injected in the presence of infection, inflammation or skin conditions in the area to be treated. After intra-articular injection, recommend that the patient avoid all intense physical activities and resume normal activities only after a few days. The contents of the pre-filled syringe are sterile. The outer surface of the syringe is not sterile. Do not sterilize again. The device is disposable.
Store below 25°C and away from heat sources. Do not freeze. Once opened, the device should be used immediately and discarded after use. Keep out of the reach of children.
Extra-articular infiltration may cause unwanted effects locally. Symptoms such as pain, warm sensation, redness or swelling may occur at the injection site. Application of ice to the treated joint is helpful in such an eventuality. Such symptoms under normal conditions disappear after a short time. Physicians should ensure that patients inform them of any side effects that have occurred after treatment.
Main component: sodium hyaluronate. Other components: sodium chloride, phosphate buffer, water for injection solutions.
Pack of 1 disposable pre-filled syringe (32.0 mg hyaluronic acid sodium salt in 2 ml buffered saline). Sterilized syringes with moist heat.